Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Olympus America, Inc.
Free shipping on orders over $99 · 30-day returns
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM is an FDA 510(k)-cleared medical device (K062581) manufactured by Olympus America, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2006. Regulation: 8.